Plain English Summary

Background and study aims Heart failure is frequent, increasing in prevalence, and is associated with high morbidity, mortality and costs. In order to reduce morbidity (illness) and mortality (death rate) in high-risk patients who have already experienced an episode of acute cardiac decompensation, appropriate comprehensive monitoring and collaborative treatment are of key importance. Unlike in other chronic diseases (e.g. diabetes mellitus) there is limited availability of comprehensive heart failure disease management within the German Health Care System, and targeted interventions considering patients individual risk profiles and their changes over time are lacking. This study compares a structured nurse-coordinated collaborative disease management intervention with usual care. HeartNet-Care-HFTM was developed in Germany for post-inpatient care and includes as modules monitoring, information, self-empowerment, improvement of compliance with pharmacotherapy, suitable discharge management and networking amongst a patients different health care providers.

Who can participate? Patients hospitalized with decompensated systolic heart failure are eligible, if aged ≥18 years and able to participate in a telephone-based intervention.

What does the study involve? Patients will be randomly allocated to one of the two study groups: HeartNet-Care-HFTM or usual care. Patients undergoing usual care receive standard post-discharge management, which typically includes a discharge letter with recommendations for increasing the dose (up-titration) of heart failure drugs and lifestyle modifications, and an appointment with a general practitioner or cardiologist within 14 days of discharge from hospital. While still hospitalized, patients undergoing HeartNet-Care-HFTM are, in addition, trained by a specialized nurse in self-control of blood pressure, heart rate and rhythm, body weight and recognition of worsening heart failure. Nurses also ascertain that patients have body scales and blood pressure gauges at home, dispense written information on heart failure drugs and materials supporting documentation of self-monitoring results, and plan subsequent telephone-based monitoring with the patients (weekly in the first month post discharge, then according to NYHA class and patients needs). Up-titration of guideline-recommended heart failure medication is an explicit goal of the intervention and pursued in collaboration with the patients general practitioner and/or cardiologist.

What are the possible benefits and risks of participation? There are no risks or disadvantages of participating in the usual care group of the study, which offers heart failure treatment according to current standards. Patients in the HeartNet-Care-HFTM group receive holistic collaborative care and monitoring. The hypothesis of the study is that this treatment will improve clinical end-points as the long-term risk of mortality and re-hospitalization, reduce heart failure symptoms and lead to better quality of life. However, these hypotheses are not yet proven, and patients will have to comply with the study protocol in HeartNet-Care-HFTM, which involves regular communication with the nurse and self-supervision. In summary, participation in the HeartNet-Care-HFTM group is associated with no risks, but a potential long-term benefit at the expense of some time.

When is the study starting and how long is it expected to run for?The study started in March 2004, recruitment lasted 4 years, the study treatment was terminated after 18 months participation of each individual patient, and follow-up will continue until December 2019.

Who is funding the study?The study is funded by the Federal Ministry of Education and Research (Germany) as part of the Competence Network Heart Failure and by central associations of statutory health insurance providers.

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Study hypothesis

On 20/08/2009 the following changes were made to the trial record:1. Scientific title was added2. Target number of participants was changed from 700 to 1,0003. Trial end date was updated from 31/12/2006 to 30/09/20094. Randomised intervention extended to 18 monthsAll other changes are recorded in the relevant fields.

On 17/04/2014 the following changes were made to the trial record:1. The follow-up period was extended to 36 and 60 months2. The anticipated end date was changed from 30/09/2009 to 31/12/20193. The target number of participants was changed from 1,000 to 1,022